Helical Suture Vessel Closure for Large Bore Access
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Solution Overview
Problem
Current vascular closure devices are inadequate for percutaneous access and closure of blood vessels for interventional procedures using catheters in the 12-24 French range, leading to complications such as bleeding and hematomas, as they are not suitable for larger diameter devices, necessitating surgical cutdowns that undermine the minimally-invasive nature of the procedures.
Innovation Solution
A vessel access and closure device that uses a rotating helical suture needle to place a running suture in the blood vessel wall, creating an access site that can be closed with a suture lock, allowing for percutaneous access and closure suitable for larger diameter interventional devices, and optionally incorporates an introducer sheath for procedural devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If percutaneous access is used for large diameter interventional devices (12-24 French), then the minimally-invasive aspect is maintained, but the ability to close the access site effectively deteriorates leading to bleeding and hematomas
Solution Approach 1:
The closure device is segmented into multiple components: an anchor element that secures to the vessel wall, a suture mechanism that can be tensioned, and a knot-tying mechanism. This segmentation allows each component to perform its specific function optimally - the anchor provides secure attachment, the suture allows adjustable tensioning, and the knot mechanism provides reliable closure - thereby enabling effective closure of large diameter access sites while maintaining percutaneous access benefits
Solution Approach 2:
The closure device is deployed and the suture is positioned through the vessel wall before the interventional procedure begins. The anchor is secured to the vessel wall in advance, and the suture is routed through the access site. This preliminary action allows the access site to be prepared for closure beforehand, and the closure mechanism to be activated immediately after device removal, ensuring reliable closure even for large diameter access sites
2Adaptability or versatility
If surgical cutdown is used to access blood vessels for large diameter devices, then the ability to insert large devices is improved, but the minimally-invasive nature of the procedure deteriorates
Solution Approach 1:
The percutaneous access device is designed with multi-functionality to handle the full range of interventional device sizes (12-24 French). The introducer sheath and dilator system can be scaled to accommodate different access site diameters, and the closure device is equally versatile in closing various sizes of access sites. This universality eliminates the need to choose between percutaneous access and surgical cutdown based on device size, allowing minimally-invasive access to be used for all large diameter interventional devices
Data Source
AI summary
A vessel access and closure device places a running suture in the wall of a blood vessel using a rotating helical suture needle that carries the suture along a helical path passing through the vessel wall, then reverses rotation to release a suture anchor attached to the distal end of the suture. A loose helical coil of suture is left behind as the helical suture needle withdraws. The device is withdrawn and replaced with a vessel dilator and an introducer sheath that opens up a larger access opening into the blood vessel and creates a pathway that passes though the helical coil of suture for introducing an interventional device into the blood vessel. After the interventional procedure is completed, the interventional device and the introducer sheath are withdrawn and the running suture is tightened and secured with a suture lock to close the access opening into the vessel.